Manager / Associate Director - Global Regulatory Strategy (Respiratory, Immunology & Inflammation) in City of Westminster

The Manager / Associate Director ensures the development of appropriate global and regional regulatory strategies and their execution for assigned assets to ensure the development program meets the needs of the key markets identified and the Medicines Profile (and is consistent with the Medicines Development Strategy / Integrated Asset plan).

• Proactively develop regulatory strategies that will deliver the needs of the local region(s), taking into account the needs of other regions globally.
• Implement the regional strategy(s) in support of the project globally.
• Manage regulatory interactions and the review processes in local regions.
• Ensure appropriate interaction with global/regional counterparts and commercial teams in local region.
• Ensure compliance with global/regional requirements at all stages of product life.
• Assess precedent, regulatory intelligence and competitive environment from a regulatory perspective for the region and the impact this will have on the regulatory strategy for an asset.

We are seeking a talented Regulatory Affairs professional with strong knowledge / experience to join our Respiratory, Immunology & Inflammation (RII) Global Regulatory Strategy team. This role reports directly to a Director (Team Lead) for Therapeutic Groups (RII). This role is a great opportunity to be instrumental in developing and delivering subject matter expertise across GSK. As this role is multi-faceted and includes liaising with a wide variety of key-stakeholders you must have strong experience of working in complex technical situations, with demonstrable clear problem-solving approach to your work. Strong people skills and a proven ability to influence people to achieve and drive performance are also pre-requisites for this role. Degree-educated in relevant scientific or technical discipline (or very strong relevant experience).

• Relevant regulatory affairs experience in the EU and/or US and other major markets. Experience should include, for example, developing and implementing regional strategies, managing regulatory interactions, submissions, and review processes.
• Clinical regulatory experience is a must, with knowledge of all phases of the drug development process.
• Ability to develop necessary specialist knowledge for the product or area of medicine.
• Proficiency in digital tools and AI to enhance project delivery and drive efficiency and innovation.

Preferred Qualifications:

• Experience of all phases of the drug development process in regulatory affairs.
• Knowledge of clinical trial and licensing requirements in all major countries in the region and ideally knowledge of other key Agency processes globally.
• Experience in relevant therapy area (especially Immunology & Inflammation) is a plus., Business Resilience, Communication, Digital Fluency, Matrix Leadership, Pharmaceutical Regulatory Compliance, Policy Advocacy, Regulatory Strategies, Resource Management, Stakeholder Management

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people's lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. We're uniting science, technology, and talent to get ahead of disease together.

Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale. People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are. Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a Recruitment FAQ guide.

• If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges $138,600 to $231,000. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.
• Belgium Salary Range / Fourchette salariale - Belgique: EUR 89,250 to EUR 148,750The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate's skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the candidate's skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate's skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria.